Allogene Therapeutics, Inc. Common Stock Citigroup’s Biopharma Back to School Summit 2026

Thank you very much, Sam.

Yeah. It's been a very productive year in 2026 so far. Beginning with our leading program, we released some data in April from an interim futility analysis. We also are moving very briskly through enrollment in our phase I program, which is a novel therapeutic CAR T-cell product in autoimmune disease indications. We'll have some data from that program later this year at an upcoming conference. That's setting us up for a very exciting, busy year of catalysts in 2027.

Yeah. So I took over as CEO on July 1st of this year. Before that, I spent 3 and a half years as the head of R&D and Chief Medical Officer. So the programs that we will discuss today are programs that I designed and launched as the head of R&D. So it is quite a natural transition for me to step into the CEO role. So I have a very clear mandate from our board and shareholders, and internally, the plan is to continue to execute on our main programs, the pivotal cema-cel program and ALPHA3, and then the RESOLUTION study with ALLO-329. And really, those are going to be the focus for the coming months and years. We also have a very exciting preclinical pipeline. We have shared a little bit of data here and there at medical conferences this year. We have got some more coming up.

Really, it is a focus on delivering on the lead programs and then continuing to build out the pipeline.

Yeah. The study itself is a randomized trial of cema-cel, which is an off-the-shelf anti-CD19 CAR T-cell. The study is designed in a novel way where we are looking to see whether patients who have completed first-line treatment for their non-Hodgkin's lymphoma, B-cell-related non-Hodgkin's lymphoma, but remain positive for minimal residual disease using an ultrasensitive MRD test at the end of first-line therapy. Those patients who are MRD positive come into the study. Then they are randomized either to a dose of cema-cel, which is an off-the-shelf CAR T-cell, or the standard of care, which is just observation, a surveillance program. The analysis that you just alluded to occurred in April. It was a preplanned safety and futility analysis where we looked at 12 patients in each of these two arms.

Rather than looking at the primary endpoint of the study, which is EFS, we looked at the ability for cema-cel to eradicate the residual disease. Everyone who comes into the study is MRD positive and who went from MRD positive to MRD negative. As you mentioned, we did have a positive outcome there. We saw about a 42% differential between the two arms, 7 out of 12 patients in the MRD arm. Oh, sorry, in the cema-cel arm cleared their MRD, and 2 out of 12 in the observation arm cleared. When we revealed these data, and we were internally examining them, we asked ourselves the same question that you just asked: What does this mean for the potential EFS analyses that are upcoming?

In 2027, we have a planned interim event-free survival analysis, and then in 2028 is the primary. Overall, the study is designed to detect a 50% reduction in risk of EFS events. We have to allocate the alpha spend between the 2027 and the 2028 analyses. We actually have a very small amount of alpha allocated to the interim analysis in mid-2027, and the majority of the alpha is reserved for the primary. When we saw this MRD differential back in April, first of all, we were overjoyed with the amount of signal that seemed to be coming from the cema-cel arm, and it gave us a great deal of confidence that this study was going to be positive when it was completed.

As it pertains to the interim EFS analysis next year, that is a TBD, right? Because it is a small amount of alpha, which means the effect size would need to be overwhelmingly positive, probably to a degree that is maybe even a little bit greater than what we saw at the interim futility. Honestly, that is an independent data monitoring committee review of that data. They have a decision to make whether stop the study for efficacy or continue the study. We are focused solely on enrolling the trial, ensuring that we have an overall positive outcome because we believe that outcome would transform the way medicine is conducted for these patients.